Quality Engineer II — Computer System Validation & QA

BioAgilytix; Durham (NC); Sur place; USD 85 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Account

Paid Time Off

Parental Leave

Paid Holidays

401k with Employer Match

Employee Referral Program

Résumé du poste

BioAgilytix is seeking a Quality Engineer II to provide QA oversight of computer validations and equipment qualifications. This role requires strong knowledge of GxPs and regulatory standards, and collaboration across cross-functional teams to ensure validation success.

The position focuses on maintaining validated state across systems (LIMS, ELN, QCBD) and supporting regulatory inspections, change controls, and deviation investigations. Office-based in a fast-paced, science-driven environment.

Qualifications

• Bachelor’s degree in engineering, IT, or related discipline.
• 5+ years’ experience in pharmaceutical/GxP environment.
• Direct hands-on experience with computer systems validation and equipment qualification.
• Familiarity with GxP regulations (FDA, EU, ICH, USP).

Responsabilités

• Provide QA oversight of computer system validation and equipment qualification programs.
• Ensure compliance with GxPs and 21 CFR Part 11.
• Review validation documentation and deviations, sponsor inspections support.
• Lead/vendor qualification activities and change control processes.
• Maintain QA documentation and participate in risk assessments.

Connaissances

GAMP guidelines

QA oversight

Computer system validation

Equipment qualification

FDA/ICH knowledge

IT infrastructure

Formation

Bachelor’s degree in engineering/IT

Outils

ZenQMS

Blue Mountain

Description du poste

BioAgilytix is seeking a Quality Engineer II to provide QA oversight of computer validations and equipment qualifications. This role requires strong knowledge of GxPs and regulatory standards, and collaboration across cross-functional teams to ensure validation success.

The position focuses on maintaining validated state across systems (LIMS, ELN, QCBD) and supporting regulatory inspections, change controls, and deviation investigations. Office-based in a fast-paced, science-driven environment.